FEATURED EDITORIAL
What may turn out to be an instructive anomaly emerged at at the JP Morgan Healthcare Conference. Across eight roundtable discussions convened by biopharma investment advisors – covering topics such as Avoidable Drug Development Pitfalls and The Emergence of Highly Competitive Chinese and Korean Biotech – the one where nary a soul showed up was titled U.S. Manufacturing. “I don’t quite understand it,” says Ali Pashazadeh, Treehill Partners founder. Here's a close investigation.
- New ISPE Framework Targets Uncertainty In Pharma's AI Deployment
- Facility Considerations When Retrofitting Legacy Sites For ADCs
- The Metaphoric Rise Of Outsourcing
- In Vivo's Biggest Threat — Comparison To Old Models
- Managing Supply Chain Risk In Scale-Up And Multisite Trials
- The Industrialization Of Advanced Modalities
- The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
GUEST COLUMNISTS
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In Vivo's Biggest Threat — Comparison To Old Models
In vivo CAR-T is not simply ex vivo without a manufacturing step. It is a different modality that relies on biological systems to regulate outcomes.
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Managing Supply Chain Risk In Scale-Up And Multisite Trials
Scaling trials across sites can lock in supply risk early. Learn how biologic variability, long lead times, and multisite complexity threaten trials and how to spot warning signs fast.
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The 5-Layer Fix For AI Failure In Pharmaceutical Manufacturing
The promise of AI is colliding with the harsh reality of data chaos in pharma manufacturing. This article explores why most AI investments fail, and a 5-layer solution.
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Why Use Total Organic Carbon Analysis For Cleaning Validation?
Total organic carbon analysis is probably the most “fit for use” analytical method to validate cleaning processes, particularly within a science- and risk-based approach.
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Global Clinical Supply — Confronting Persistent Challenges With Strategic Action
From regulatory fragmentation to cold chain risks, discover how strategic action, data visibility, and resilient design keep clinical trials on track.
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December 2025 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.
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Do's And Don'ts Of Material Handling When Retrofitting For ADCs
Antibody-drug conjugate manufacturing includes extremely dangerous ingredients, and most legacy facilities lack the features and flows for safe handling.
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Building Enterprise Resilience From QRM Signals
Turn enterprise resource management (ERM) from a checklist into a true decision system — so risk informs everyday choices before quality events become supply disruptions, delays, or regulatory exposure.
PHARMA OUTSOURCING WHITE PAPERS
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Small Molecule API Production: Unveiling The Impact Of Fermentation
Technological developments have led to growth in the suitability of fermentation for a myriad of applications. Explore the impact of the evolution of synthetic biology and supporting technologies on modern fermentation practice.
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The Critical Role Of Comparative Analytical Assessments
Utilizing expert analytical testing services can unlock the potential of biosimilars and bring cost-effective treatments to market faster.
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Optimizing DSP Development: Faster Timelines, Lower Costs, And High-Quality Processes
The biopharmaceutical industry faces growing downstream processing challenges in purifying complex biologics efficiently and at scale.
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Random And Semi-Targeted Integration In Cell Line Development
While semi-targeted approaches may offer precision, uncover how they may fall short in overall efficiency and productivity, especially in late-stage manufacturing.
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The Power Couple: CRISPR And Oligonucleotides
Oligonucleotides are reshaping genetic medicine, with CRISPR accelerating demand for complex gRNA sequences. Learn about the manufacturing challenges that define the next phase of oligo development.
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Overcoming Challenges To High-Concentration Formulation Development
Explore how the S-HiCon™ platform optimizes high-concentration therapeutic antibody formulations, overcoming stability and manufacturability challenges to deliver safe, effective therapies.
PHARMA OUTSOURCING APP NOTES & CASE STUDIES
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